In medical diagnostic practice, biological specimens of blood and other bodily fluids are obtained from a patient and subsequently analyzed for the presence of infectious pathogens, biochemical constituents, or the like. Specimen collection and processing routinely involve the handling of used and contaminated medical needles by health care workers. This invention provides a means and method whereby liquid specimen collection and transfer procedures are significantly safer and less hazardous for medical technicians, nurses and the like.
With conventional devices for collection of such specimens, there is a very real danger from accidental needlestick injury associated with transferring the fluid specimen from the patient into the blood specimen collection tube, in which latter the specimen is transported to the laboratory for analysis. Such transfer is commonly effected by manual manipulations of a syringe, a pointed needle cannula, and a receptacle or other sterile receiver having a puncturable rubber stopper.
In one common procedure, a syringe barrel, which is provided with a male connector fitting, is filled with blood. This is often accomplished by connecting the male fitting of the syringe to the female fitting of the access port of a venous access line. The line provides the fluid conduit between the blood vessel and the internal chamber of the syringe barrel. The syringe is filled with blood by withdrawing blood from the blood vessel through the conduit. The blood-filled syringe is then disconnected from the line and an unshielded conventional syringe needle, with a female fitting, is affixed to the syringe barrel. While the medical technician holds the blood specimen collection tube or other specimen receiver in place with one hand, the needle of the blood-filled syringe is used to puncture the rubber stopper or septum of the blood specimen collection tube. The process of puncturing the collection vessel stopper is accomplished by the technician holding the syringe with the other hand and aiming the blood-filled syringe/needle assembly to the appropriate stopper penetration spot.
The above described practice of holding a collection tube in one hand and moving the blood-filled syringe/needle assembly toward the tube stopper with the other hand constitutes a grave danger for the medical technician. If for example, the technician misses the tube stopper and punctures instead the hand holding the collection tube, the technician could contract an infection from any pathogens, such as the AIDS virus or a hepatitis virus present in the blood specimen.
Of further significance, blood specimen collection tubes or bottles used commonly for diagnostic procedures have a variety of access port diameter sizes. The access port is the rubber stopper or septum which serves as the closure of the container which is punctured by the needle of the transfer device needle, such as the type commonly affixed to a syringe barrel. As presently practiced, needles used for the syringe in specimen transfer procedures are not shielded and are commonly implicated in needlestick injuries of health care givers.
In standard blood collection devices, multiple sample adapters are provided at the sample collection end of indwelling catheters or winged needle sets. The multiple sample adapter is a needle which is assembled with a flexible rubber sleeve which reversibly covers the needle as it penetrates and is withdrawn from rubber stoppers of liquid specimen collection vessels. The purpose of the sleeve is to interrupt blood flow after the needle is withdrawn from the tube stopper. Flow is reinitiated after the sleeve is pushed back as the needle penetrates another stopper.
Although the sleeve is helpful in stopping blood flow from the source of the blood for sample collection, it does not prevent the health care worker from sustaining an accidental needle stick injury. Thus, some multiple sample adaptor devices are designed to be reversibly assembled with needle shields in which the needle is recessed within a long tubular or short bell-shaped guide which fits over the blood specimen collection ports. The needle is recessed within the tube guide, and this configuration partially blocks the direct exposure of the hands of the technician to the contaminated needle.
The deficiencies of the current devices are that a multitude of combinations of tubular guides or bell-shaped guides require the technician to assemble and disassemble various multiple sample needles with guides of different sizes to accommodate the variety of specimen tube stopper port and specimen containers used commonly for either blood chemistry or for determination of the presence of blood-borne pathogens. For example, blood chemistry tubes have narrow-diameter rubber stopper ports; whereas, many blood culture specimen bottles, used for growing infectious pathogens to diagnose infections, have relatively wide septum ports. Thus, a narrow tube guide for chemistry tubes will not fit over wide port septums.
Of further significance is that conventional syringe needles have no multiple sample features and no provisions for tube guides or large guides for shielding the needles during fluid specimen transfer procedures from syringe barrel to liquid specimen container.